The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.
Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. Acute cholecystitis is one of the most frequently encountered acute surgical conditions. It is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain. Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is still debatable. Early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. Investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients. In fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. Previously, studies demonstrating that GB34 has specific effects on the motility of bile ducts were published. More recently, researchers were able to demonstrate that GB34 electro acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using an experimental rabbit model of acute cholecystitis. Additional functional MR studies were used to distinguish the neural specificity of the acupuncture points. GB34 were found to induce a specific response pattern which is more significant in motor functions in brain. Furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles.
Niğde Ömer Halisdemir University Training and Research Hospital
Niğde, Turkey (Türkiye)
Perceived pain
Measured by Visual Analog Scale scored between 0 and 10. Zero refers to no pain whereas 10 refers to the worst pain perceived by the patient.
Time frame: From hospital admission (baseline) until hospital discharge, with VAS assessments performed every 12 hours, assessed up to a maximum of 168 hours.
Analgesic dosage
Total dosage of analgesic administered in mg
Time frame: From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.
Guarding
presence or absence of abdominal guarding assessed by investigators. Guarding is defined as a spasm of muscles that minimizes the motion or agitation of sites that are affected by injury or disease.
Time frame: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
Abdominal tenderness
presence or absence of abdominal tenderness assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
Time frame: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
Oral intake
if patients tolerate oral intake or not
Time frame: From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).
Antibiotic dosage
Total antibiotic dose administered during hospitalization (mg)
Time frame: From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours
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Direct bilirubin
Direct bilirubin levels expressed in mg/dL
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Total bilirubin
Total bilirubin levels expressed in mg/dL
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Amylase
Amylase levels expressed in U/L
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
GGT
Gamma glutamyl transferase levels expressed in U/L
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
ALP
Alkaline phosphatase levels expressed in U/L
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
ALT
Alanine aminotransferase levels expressed in U/L
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
AST
Aspartate aminotransferase levels expressed in IU/L
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
CRP
C-reactive protein levels expressed in mg/L
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
PLT
platelet count in microliter
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
LYM%
percent of lymphocytes
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
NEU%
percent of neutrophils
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
WBC
White blood cell count in microliter
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Hb
Hemoglobin values expressed as g/dL
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours